Au­tomat­ing se­da­tion to speed re­cov­ery

Modern Healthcare - - INNOVATIONS - By Adam Ruben­fire

Some hos­pi­tals and gas­troen­terol­o­gists were look­ing for a way to im­prove the se­da­tion of pa­tients re­ceiv­ing screen­ing colono­scopies and up­per en­do­scopies while cut­ting out the costs as­so­ci­ated with hav­ing an anes­the­si­ol­o­gist present for the pro­ce­dures.

Mi­da­zo­lam and fen­tanyl, com­mon seda­tives used by gas­troen­terol­o­gists, can lead to in­ad­e­quate se­da­tion of pa­tients, who may take hours to re­cover. Propo­fol has fewer side ef­fects but nor­mally has to be ad­min­is­tered by an anes­the­si­ol­o­gist, which boosts costs.

Ethicon, a John­son & John­son sub­sidiary, de­vel­oped a com­puter-as­sisted se­da­tion sys­tem called Sedasys. De­spite the con­cerns of anes­the­si­ol­o­gists, the sys­tem was ap­proved by the Food and Drug Ad­min­is­tra­tion in 2013 to de­liver propo­fol for mim­i­nal-to-mod­er­ate se­da­tion for colono­scopies and up­per en­do­scopies with­out an anes­the­si­ol­o­gist in the room. As a con­di­tion of ap­proval, Ethicon agreed to re­quire an anes­the­si­ol­o­gist be on-call dur­ing pro­ce­dures and to sell the sys­tem for use only by providers cre­den­tialed for the use of propo­fol for mod­er­ate se­da­tion.

Last Septem­ber, Vir­ginia Ma­son Med­i­cal Cen­ter in Seat­tle be­came the first hos­pi­tal to start us­ing the Sedasys sys­tem. Since then, Rhode Is­land Hos­pi­tal in Prov­i­dence; ProMed­ica Toledo (Ohio) Hos­pi­tal; Grace Med­i­cal Cen­ter in Lubbock, Texas; and Loma Linda (Calif.) Uni­ver­sity Med­i­cal Cen­ter have started us­ing the sys­tem.

A Vir­ginia Ma­son spokesman said the hos­pi­tal de­cided to use the Sedasys sys­tem to shorten pa­tient re­cov­ery, in­crease sat­is­fac­tion, and al­low pa­tients to be bet­ter able to dis­cuss re­sults and in­struc­tions post­pro­ce­dure. It also made good busi­ness sense. Faster dis­charges have al­lowed the hos­pi­tal to in­crease its vol­ume of up­per en­do­scopies and colono­scopies from an av­er­age of six to eight a day.

Dr. Otto Lin, a Vir­ginia Ma­son gas­troen­terol­o­gist, said the Sedasys sys­tem frees him from hav­ing to con­stantly mon­i­tor and ad­just se­da­tion, which can be dis­tract­ing while try­ing to per­form scop­ing pro­ce­dures. Hav­ing the ma­chine ad­min­is­ter propo­fol is bet­ter be­cause the pa­tient’s se­da­tion is steady rather than go­ing through peaks and troughs, which of­ten oc­curs with the other seda­tives.

Dur­ing the piv­otal study for Sedasys, 99% of pa­tients se­dated by the ma­chine re­cov­ered from the pro­ce­dure in only 10 min­utes, com­pared with 75% of pa­tients who re­ceived mi­da­zo­lam or fen­tanyl, said Paul Brugge­man, gen­eral manager of Ethicon’s Sedasys busi­ness. Pa­tients also had fewer episodes of oxy­gen de­sat­u­ra­tion when the sys­tem was used. Clin­i­cians re­ported sig­nif­i­cantly higher sat­is­fac­tion with the de­vice com­pared with tra­di­tional seda­tives, and pa­tients also gave it slightly higher sat­is­fac­tion rat­ings.

In a pro­ce­dure us­ing the Sedasys sys­tem, the physi­cian mea­sures an ini­tial dose of propo­fol. Af­ter that, the sys­tem au­to­mat­i­cally re­duces or stops in­fu­sion of propo­fol if a pa­tient’s blood oxy­gen level, heart rate, re­s­pi­ra­tory rate or other vi­tals in­di­cate they’re overse­dated or hy­per­ven­ti­lat­ing. The sys­tem also ad­justs se­da­tion based on pa­tient re­spon­sive­ness, which the ma­chine mea­sures by re­peat­edly ask­ing the pa­tient through an ear­piece to squeeze a hand­set. Sedasys also de­liv­ers an au­to­mat­i­cally determined amount of oxy­gen to a pa­tient’s nose and mouth based on the pa­tient’s oxy­gen sat­u­ra­tion lev­els.

The ma­chine doesn’t in­crease se­da­tion on its own. A doc­tor or nurse ini­ti­ates an in­crease, and the ma­chine has lock­out timers and dose lim­its to en­sure that physi­cians un­der­stand the full ef­fect of a dos­ing de­ci­sion be­fore in­creas­ing the dose.

Dr. John Aben­stein, pres­i­dent of the Amer­i­can So­ci­ety of Anes­the­si­ol­o­gists, said he sees the Sedasys sys­tem as a “safety de­vice,” be­cause even anes­the­si­ol­o­gists can over­look the prob­lem of pa­tients hy­per­ven­ti­lat­ing. Still, he said it’s un­likely that Sedasys and other ma­chines will ever re­place anes­the­si­ol­o­gists, who still will be needed for more com­plex pro­ce­dures.

The Sedasys sys­tem has been used for 3,200 Vir­ginia Ma­son pa­tients, nearly ev­ery pa­tient who un­der­went a colonoscopy or up­per en­doscopy since the ma­chine was in­stalled. Lin said the hos­pi­tal’s anes­the­si­ol­o­gists were sup­port­ive, not­ing it would have been dif­fi­cult to in­tro­duce the tech­nol­ogy with­out their sup­port. Pre­vi­ously, the hos­pi­tal’s anes­the­si­ol­o­gists gen­er­ally did not par­tic­i­pate in th­ese pro­ce­dures.

Ethicon has a goal of se­dat­ing 20,000 to 30,000 pa­tients across the coun­try this year. The com­pany de­clined to pro­vide pro­jected sales fig­ures or the de­vice’s price.

GEN­ERAL MANAGER OF SEDASYS

Paul Brugge­man

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